20 años de angioplastia primaria para el tratamiento del infarto. experiencia y evolución de las...
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Conferencia magistral "20 años de Angioplastia Primaria para el tratamiento del Infarto. Experiencia y evolución de las redes de infarto" del Dr. Petr Widimsky durante la XXV Reunión Anual de la Sección de Hemodinámica y Cardiología Intervencionista (SHCI) de 2014 en Córdoba.TRANSCRIPT
20 years of Primary PCI for STEMI:Czech experience and evolution of networks.
Petr WidimskyCharles University Prague &
University Hospital Kralovske Vinohrady, PragueCzech Republic
How to reperfuse the obstructed route ?Before 1985: no routine treatment available1986-1993: dissolving the clot (thrombolysis) in 25% of all STEMIs1993-2002: reperfusion & revascularization (p-PCI) for 50% of STEMIs (locals only)After 2002: reperfusion & revascularization (p-PCI) for all STEMIs (transport)
Geoff Hartzler (USA) 19821st primary PCI
Felix Zijlstra & Zwolle Group (NL) 1988-931st randomized trial on primary PCI
Otto Klein (CZ) 19291st diagnostic
cardiac catheterization Andreas Gruntzig (CH) 19771st PTCA
„1st Zwolle trial“ (NEJM 1993):PCI superior to TL for patients directly admitted to PCI centers.
SK
(n=72)
P-PCI
(n=70)
p value
IRA recanalization 68% 91% 0,02
Discharge EF 45% 51% 0,004
Re-MI 13% 0% 0,003
Post-MI angina 19% 6% 0,001
1990 cup of coffee in Rotterdam1993-4 PCI training in Zwolle1995 end of thrombolysis in Prague1997-9 the PRAGUE-1 study2002 Czech STEMI guidelines2008 Stent for Life
Thrombolysis(50% success rates7% reocclusion risk)
Primary PCI (90% success rates3% reocclusion risk)
Modern therapy of AMI:
Thrombus removal,
Flow restoration
Reperfusion methods in STEMI:
Primary PCI:•90% success rate
•8% death /re-MI /stroke
•3% reinfarctions
•1% strokes
•3-7% mortality in trials
•5-9% mortality in registries
Thrombolysis:•50% success rate
•14% death /re-MI /stroke
•7% reinfarctions
•2% strokes
•6-9% mortality in trials
•10-17% mortality in registries
LIMI + PRAGUE-1(Metaanalysis from: F. Vermeer, Heart 1999; 82:
426-31; P. Widimský, Eur Heart J 2000; 21: 823-31)
13
11
7
20
14
8
2
4
1
0
2
4
6
8
10
12
14
16
18
20
Mortality +/reMI Stroke
Thrombolysis
Both
PrimPTCA
%
N = 524
0
2
4
6
8
10
12
ASSENT4 (2005) PRAGUE1 (1999)
Facilit.PCI
Prim.PCI
F. v/d Werf 2000: Routine transport of STEMI pts. to PCI centers is not acceptable (EHJ 2000, editorial k PRAGUE)
F. v/d Werf 2006: ASSENT-4 (Lancet 2006; 367: 569–78)
37%
42%
PRAGUE-2: 30-days outcomesEur Heart J. 2003 Jan;24(1):94-104
10
6,80
15,2
8,4
0
2
4
6
8
10
12
14
16
Mortality +/re-MI/stroke
TL
PCI
P = 0,12
P < 0,003
Metaanalysis of 23 studies TL vs. PCI(Keeley et al., Lancet 2003; 361: 13-20)
9
7 7
32
1
14
8
0
2
4
6
8
10
12
14
Mortality Re-MI Stroke Comb.end-
point
TL
PCI
% n=7739
Czech Republic:Experience with primary PCI
and STEMI networks
Čas lék čes 1983; 122: 694-6.
Dec. 20, 1982
Real-life STEMI mortality in various hospital types
Czech Republic 1995
29
17 17
8
0
5
10
15
20
25
30
In-hospital mortality
No cardiologist onduty
Cardiologist day-hours
Cardiologist 24/7, butno PCI
Cardiologist + PCI24/7
Change of reperfusion strategy in University Hospital „Vinohrady“ Prague: October 5, 1995 thrombolysis declared non-lege artis
0
2
4
6
8
10
12
Mortalita STEMI
1994
1996
5-leté přežívání po PCI
5-leté přežívání po trombolýze
STEMI guidelies of the Czech Society of Cardiology
PCIPCIPCIPain-ECG
3-12
hours
TLPCIPCIPain-ECG
< 3 hours
ECG-PCI
> 90 min.
ECG-PCI
30-90 min.
ECG-PCI
< 30 min.
STEMI
(Cor et Vasa 2002; 44: K123-143)
….. The world first guidelines declaring p-PCI as first treatment option !
• 2002 Czech Society of Cardiology
• 2003 European Society of Cardiology
• 2004 American College of Cardiology / AHA
Evolution of PCI rates in the Czech R.
3201829
9270
16338
2167622545
21624
0
5000
10000
15000
20000
25000
1990 1995 2000 2002 2004 2009 2013
PCI/rok/ČR
PCI/rok/ČR
PRAGUE-11999
PRAGUE-22002
P-PCI networks Czech Rep.
During 1999 – 2005 period the implementation of the „PRAGUE“ trials resultscompletely abolished mortality differences between hospital types
8
18
0
5
10
15
20
In-hospital mortality
Tertiary PCI centers Hospitals without cath-lab
6,8 6,9
0
5
10
15
20
In-hospital mortality
Tertiary PCI centers Hospitals without cath-lab
Stent for Life
≥600 p-PCI / million / year400-599 p-PCI / million / year200-399 p-PCI / million / year<200 p-PCI / million / yearData not known
Annual Incidence of Primary PCIs
SFL prokázal, že národní strategie léčby infarktu trombolýzou vede k tomu, že 46% nemocných s infarktem de facto není vůbec léčeno.Národní strategie léčby infarktu primární PCI (CZ, NL) sníží tento
počet na pouhých 7%.
7
46
0
5
10
15
20
25
30
35
40
45
50
No reperfusion used
NL + CZ
Countries withthrombolysisdominance
% from all STEMI
And what aboutNon-STEMI ?
Špaček R. et al.: VINO Study.Eur Heart J. 2002 Feb;23(3):230-8.
30days 6months
Invasive
Conserv
7.5%
13.4%
1.6%3.1%
p<0.05
•Unstable angina is disappearing in the current era of hs-Tn…..•…..We can expect, that patients with coronary artery diseasewill again (as many years ago) be classified as having either (a) angina pectoris or (b) acute myocardial infarction.
•A requiem is a choral musical work that is performed at the funeral of a great personage or at the close of an importantera. Has not the time arrived to prepare a requiem forunstable angina ?
(Circulation. 2013;127:2452-2457.)
Hot topics inacute PCI for AMI
Dr Adeel Shahzad
Dr Rod Stables (PI)
Liverpool Heart and Chest Hospital
Liverpool, UK
How Effective are
Antithrombotic Therapies in PPCI
Bivalirudin Heparin
GPI Bailout GPI Universal
ACUITY 9 % 97 %
ISAR REACT 4 0 % 100 %
HORIZONS 7 % 98 %
EUROMAX 9 % 70 %
↑ bleeding with ↑ GPI use
• Single centre RCT
• Trial recruitment: Feb 2012 - Nov 2013 22 months
• Bivalirudin v Unfractionated Heparin
• STEMI patients
• Randomised at presentation
• Acute phase management with Primary PCI
• Philosophy for clinical teams:
• Assess ‘Every Patient - Every Time’
• Dual oral anti-platelet therapy pre-procedure
• Heparin: 70 units/kg body weight pre-procedure
• Bivalirudin: Bolus 0.75 mg/kg
Infusion 1.75 mg/kg/hr - procedure duration
• GPI - Abciximab
• Selective (‘bailout’) use in both groups
• ESC guideline indications
Assigned to Heparin 914
Included in analysis 907
915 Assigned to Bivalirudin
905 Included in analysis
Consent not available in surviving patients
Consent not available in surviving patients
7 10
Received allocated Rx 900
Received no study drug 14
Treatment cross-over 0
LMWH pre-procedure 3
907 Received allocated Rx
7 Received no study drug
1 Treatment cross-over
4 LMWH pre-procedure
Characteristic Bivalirudin (%) Heparin (%)
P2Y12 use - Any 99.6 99.5
- Clopidogrel 11.8 10.0
- Prasugrel 27.3 27.6
- Ticagrelor 61.2 62.7
GPI use 13.5 15.5
Radial arterial access 80.3 82.0
PCI performed 83.0 81.6
Bivalirudin Heparinn % % n
MACE 79 8.7 % v 5.7 % 52
Absolute risk increase = 3.0% (95% CI 0.6, 5.4)
Relative risk = 1.52 (95% CI 1.1 – 2.1) P=0.01
Event curve shows first event experienced
Bivalirudin Heparinn % % n
Death 46 5.1 % v 4.3 % 39
CVA 15 1.6% v 1.2% 11
Reinfarction 24 2.7% v 0.9% 8
TLR 24 2.7% v 0.7% 6
Any MACE 79 8.7 % v 5.7 % 52
Bivalirudin Heparinn % % n
Definite 23 3.3 % v 0.7 % 5
Probable 1 0.1 % v 0.1 % 1
Acute 20 2.9 % v 0.9 % 6
Subacute 4 0.6% v 0% 0
ARC definite or probable stent thrombosis events
Bivalirudin Heparinn % % n
Major Bleed 32 3.5 % v 3.1 % 28
Relative risk = 1.15 (95% CI 0.7 - 1.9) P=0.59
Major Bleed BARC grade 3-5
• A unique study with 100% recruitment of eligible patients
Use of heparin rather than bivalirudin
• Reduced rate of major adverse events (NNT = 33)
• Fewer stent thromboses and reinfarction events
• Consistent effect across pre-specified subgroups
• No increase in bleeding complications
• Potential for substantial saving in drug costs
• 1. Bivalirudin is better drug and despite its price is cost-
effective.
• 2. Bivalirudin is better drug, but heparin is more cost-
effective.
• 3. Bivalirudin is just an expensive alternative to heparin
(both drugs are equally effective)
• 4. Heparin is better and bivalirudin should be abandoned.
After infarct artery PCI, patients were randomized to (A) no further PCI procedures or (B) immediate preventive PCI in noninfarct arteries with more than 50% DS (preventive PCI). Staged PCI in patients without angina was discouraged.
What was known before PRAMI: evidenceand guidelines
Ph.Gabriel StegDHU-FIRE, Hôpital Bichat, Assistance Publique – Hôpitaux de Paris,
Université Paris – Diderot, INSERM U-698, Paris, France,
French Alliance for Cardiovascular clinical Trials
and Imperial College, Royal Brompton Hospital, London, UK
Worse Prognosis in Patients with MVD vs SVD After
Primary PCI
57Parodi et al. Heart 2005;91:1541-44
Consecutive Patients Undergoing Primary PCI in a High Volume Center (N=1009)
n=511
n=498
After ACS, as many recurrent events are related to “non culprit” and “culprit” lesions
Findings from the PROSPECT study:
MACE after Successful, Uncomplicated PCI in 697 Patients with ACS
Stone GW et al. N Engl J Med 2011;364:226-235
Complete vs Incomplete Revasc in DES Era: An
analysis from the NY State Database
Death Death/MI
Adjusted HR 1.23, P=0.01 Adjusted HR 1.27 P=0.002
Hannan et al. JACC Intv 2009;2:17-25
APEX-AMI: Multivessel PCI during initial
Procedure Associated with Increased Death
61Toma M, Buller CE et al. Eur Heart J 2010; 31:1701-7.
Non-IRA Revascularization routinely after Primary PCI –a Meta Analysis
Bainey K, Mehta SR, Welsh R, AHJ 2013
Same-sitting:favours culprit-only
Staged:favours routine revasc
Steg PG, James SK et al. Eur Heart J 2012
ESC STEMI guidelines
3.5.4.9 Revascularization strategy for ST-segment elevation myocardial infarction
with multivessel disease
Apart from patients in cardiogenic shock, and in patients with continuous ischaemia after
opening the supposed culprit lesion, performing PCI of non-culprit vessels in the acute
setting is generally discouraged. The best strategy for STEMI patients with multivessel
disease, who underwent primary PCI of the infarct-related artery in the acute phase with
remaining multivessel disease, is still not well established.
Among the possible strategies, two that are frequently used are either a conservative
approach—which uses medical therapy after primary PCI, and revascularization of other
arteries only if there are symptoms or evidence of ischaemia in provocative tests—or a
staged revascularization approach, using PCI or coronary bypass surgery of non-infarct
arteries several days or weeks after primary PCI, often after confirmation of the stenosis
severity with measurements of fractional flow reserve. A multidisciplinary approach is often
needed, including a heart team and appropriate informed consent of the patient.
In STEMI patients with multivessel disease initially treated with primary or post-thrombolysis
culprit-artery PCI and confirmed presence of ischaemia in non-infarcted territories, staged
revascularization may be performed before discharge or in the days to weeks after initial
PCI
Steg PG, James SK et al. Eur Heart J 2012
ESC STEMI guidelinesSummary of indications for imaging and stress testing
Steg PG, James SK et al. Eur Heart J 2012
Bioresorbable vascular scaffoldsin acute STEMI
(PRAGUE-19 study)
Petr Widimský, Viktor Kočka, Martin Malý*,
Libor Lisa, Tomáš Buděšínský, Petr ToušekUniversity Hospital Kralovske Vinohrady
and *Central Military Hospital
Prague, Czech Republic
Inclusion criteria Exclusion criteria - clinical Exclusion criteria - angiographic
STEMI <24 hours from
symptom onset
Killip III-IV class (i.e. high likelihood of
death within BVS absorbtion time)
Infarct artery reference diameter
<2,3 mm or >3,7 mm (i.e. not suitable
for currently available BVS sizes)
Signed written
informed consent
Any other disease with probable
prognosis <3 years
Lesion lenth >24 mm (i.e. precluding
single BVS implantation)
Indication for oral anticoagulation (e.g.
atrial fibrillation)
Extensive infarct artery calcifications
or severe tortuosity
Contraindication to prolonged DAPT or
high likelihood of non-compliance to
DAPT
STEMI caused by in-stent restenosis
or stent thrombosis
No stent: not needed (POBA, thrombus
aspiration etc.) or not possible (failed PCI
or failed stent delivery)
79/311 (25.4%) pts fullfilled the prespecified
inclusion / exclusion criteria for BVS implantation
BVS vs. other stent: cardiac death / myocardial infarction / TVR.
Number of patients available for follow-up in BVS/Control group is 40/57 at discharge, 36/48 at 1 month and 17/25 at 6 months.
Procedural result and BVS feasibility
• 85 BVS successfully implanted to 76/79 patients
• In 3 pts. BVS could not be delivered to LCX (BMS 2x succeeded, 1x failed)
• 72/76 BVS patients had ideal result (TIMI-3 flow, no residual stenosis, no angiographically visibledissection)
• 4/76 patients had TIMI-2 flow
Why BVS was not implanted to 75% STEMI patients (n = 235)
12%
37%
17%
13%
9%
1%5%
2% 4%
Reasons for exclusion PCI without stent
Too large artery (≥3,7 mm)
Killip III-IV
Artery calcifications or tortuosity
BVS size not on stock
Stent thrombosis as culprit lesion
Expected non-compliance to DAPT
Other illness with short prognosis
Oral anticoagulation
37% more STEMI pts. might receive BVS if size 4,0 mm would be available
BVS group – overall outcomes (n=76) follow-up: 21 pts. >1 year, 52 pts. >6 months, 70 pts. >1 month
• Overall mortality: 1/76 = 1.3% (1 patient with anterior STEMI treated 18 hours after symptom onset died due to septal rupture occurring 4 hoursafter P-PCI)
• Reinfarction (up to 16 months post PCI): 1/76 = 1.3% (1 BVS thrombosis3 days after stopping ticagrelor, 10 days after hospital discharge)
• Stent thrombosis: 1/76 = 1.3%
• Stroke (up to 16 months post PCI): 3/76 = 3.9% (1 ICB after electiveneurointervention 95 days post PCI, 1 TIA during elective re-CAG 47 days post PCI, 1 spontaneous TIA 10 days after p-PCI)
• Clinical restenosis (up to 10 months post PCI): 0 = 0%
Endothelization at 1 month
Endothelization at 6 months
Conclusions
• BVS implantation in acute STEMI is feasible and safe.
• With the currently available size spectrum and expirationtimes BVS can be used in 25-35% of STEMI patients. Availability of 4,0 mm size would substantially increase thisproportion.
• OCT can be used safely to control BVS implantation in STEMI.
• The study will elucidate the role of CT angiography for long-term BVS patency assessment
• Long-term follow-up will elucidate the future role of BVS in STEMI.
Three young females (37-46 years)
with acute stroke (NIHSS 12-17)
and full neurologic recovery within 48 hours
45-years mother from 3 children
11:30 sudden loss of consciousness, hemiplegia
12:30 CT scan
13:00 transfemoral angiography
13:30 thrombectomy (Solitaire)
13:45 conscious, speaking
16:00 moving (photo)
Next morning willing to go home (mRS 0)
Functional outcomes
Favourable outcome (mRs ≤2) in 48%. Mean mRs among survivors
treated within <120 minutes was 1.17 !
Our results are similar / better when compared to
endovascular treatment arms in the 3 largest
randomized trials (NEJM March 2013)
21,7 19,1 18,814,4
5259
81
58
0
10
20
30
40
50
60
70
80
90
PRAGUE-16 IMS-III trial MR Rescue trial
SYNTHESIS trial
Mortality
Death / severe invalidity
Mean mRS at 90 days
*SYNTHESIS included pts. with small strokes (NIHSS ≥2)
* * MR-Rescue included pts. with NIHSS ≥6
* **
PRAGUE trials overview• PRAGUE-1: p-PCI vs. TL vs. facil.
PCI in STEMI (transport)
• P-2: p-PCI vs. TL in STEMI
(transport)
• P-3: p-PCI for late-presenting
STEMI
• P-4: off-pump vs. on-pump CABG
for all-comers
• P-5: 24-hour discharge after
STEMI
• P-6: off-pump vs. on-pump CABG
for high risk pts.
• P-7: abciximab in cardiogenic
shock
• P-8: clopidogrel pretreatment
before PCI
• P-9: ischemic mitral regurgitation
• P-10: trimetazidine in heart failure
• P-11: platelet activity in CABG
• P-12: surgical MAZE
• P-13: multivessel PCI in STEMI
• P-14: perioperative bleeding and
ischemia in non-cardiac surgery
• P-15: renal denervation
• P-16: acute stroke intervention
• P-17: anticoagulant + antiplatelet
therapy after PCI in pts with atrial
fibrillation
• P-18: ticagrelor vs. prasugrel in
STEMI
• P-19: bioresorbable vascular
scaffolds in STEMI
Published
Unpublished (failed)
Ongoing
Hot Line / Late Breaking Clinical Trials presentations from the PRAGUE Study Group
• 1999 ESC: PRAGUE-1
• 2000 ESC: VINO
• 2002 ESC: PRAGUE-2 (30-day outcomes)
• 2002 ESC: PRAGUE-4 (early surgical outcomes)
• 2002 TCT: PRAGUE-2
• 2004 ACC: PRAGUE-4 (1-year CAG outcomes)
• 2006 WCC: PRAGUE-2 (5-yers f-u)
• 2007 ESC: PRAGUE-8
• 2009 ESC: PRAGUE-7
• 2012 ESC: PRAGUE-12
• 2013 ACC: PRAGUE-6
• 2013 EuroPCR: PRAGUE-19
• 2013 ESC: PRAGUE-14
• 2014 EuroPCR: PRAGUE-16
Ke stažení v PDF verzi:www.kardio-cz.cz
The goal of modern cardiology:
To keep the routes open !